What studies are subject to audit and/or review by the Quality Improvement (QI) Program staff?
Any studies involving human subjects that have received full or expedited review by the MCW/FH IRB are subject to audit and/or review by QI. The majority of studies audited or reviewed will be open and active, however, QI may be asked to conduct a for-cause audit of a study that is in any stage, including closed studies. Any study that is suspended by the Director of the Human Research Protection Office or an IRB Committee may be subject to an audit, in accordance with the MCW/FH IRB action guidelines.
